The session, “Research Involving Vulnerable Populations: Regulations and Guidance,” will focus on federal regulations governing research that involves with subjects that are likely to be vulnerable to coercion or undue influence such as children, prisoners, pregnant women, people with mental disabilities, or economically or educationally disadvantaged people. When studies include these populations, additional safeguards must be included in the study’s design to protect the rights and welfare of these subjects.

Federal law requires that the IRB approve studies involving some or all of these kinds of subjects. IRB applications must identify the inclusion of vulnerable populations and described the additional safeguards that will be put in place in the study for IRB review and consideration.

In order to support and supplement the release of several revised and new IRB guidance documents centered on working with vulnerable populations, the session will

Summarize the special considerations and regulatory requirements for each vulnerable population (minors/wards of the state; adults unable to provide consent; neonates; non-English speaking subjects; pregnant women/fetuses; prisoners; and students/employees); Detail group characteristics that warrant additional safeguards and discuss common safeguards to include in your study design;

Outline applicable federal, state, or local laws and policies that apply to research with vulnerable populations;

Describe special considerations for the consent process to ensure appropriate inclusion in the research; Provide participants with a chance to discuss with the IRB challenges faced when applying regulations and guidelines to this type of research.

Those attending the session are eligible to earn 1.5 credits in Continuing Nursing Education (CNE) and the session is co-sponsored by the School of Nursing.

Participants should bring lunch or a snack.

For questions or to RSVP, please call Rachel at 977-9813 or e-mail millinrm@slu.edu.

For more information and additional education opportunities visit the ‘Training and Education’ tab on the IRB Web site.

The IRB’s Brown Bag series is designed to provide the SLU research community with in-depth understanding and discussion concerning the latest policies, procedures and requirements pertaining to human subjects research. Brown Bag sessions are for SLU research professionals and coordinators as well as any student, staff or faculty member who is looking for continuing IRB education.